Methamphetamine Use DisorderPhase 2SHIFTNCT07509112
Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study
A Phase 2 study testing 12 weeks of weekly subcutaneous semaglutide injection in people with Methamphetamine Use Disorder, run by Kirby Institute at 5 sites in Australia.
Trial summary
Methamphetamine use disorder is a major public health concern in Australia and globally. GLP-1 medications such as semaglutide (e.g. Ozempic) are approved for diabetes and medication, and may potentially affect craving for other substances apart from food. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- 12 weeks of weekly subcutaneous semaglutide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesAustralia
- Study dates
- Sep 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided voluntary, written informed consent;
- Aged 18 years or older;
- Diagnosed with moderate to severe methamphetamine use disorder (DSM-5 criteria);
- Self-reported methamphetamine use on at least 14 of past 28 days and a positive oral fluid drug screen for amphetamine/methamphetamine;
- Willing and able to comply with study procedures and follow-up visits;
- People of child-bearing potential must agree to use effective contraception during treatment and during the 60 days after treatment end.
Who cannot join
- Uncontrolled medical or psychiatric conditions that may interfere with participation;
- Body mass index less than 22 kg/m2;
- Confirmed diagnosis of diabetes mellitus (either known history of diabetes; concomitant treatment with insulin, metformin, sulfonylureas, thiazolidinediones, SGLT2 inhibitor, DPP4 inhibitor; or HbA1c >6.5 at screening);
- Currently taking a GLP-1 receptor agonist;
- Known hypersensitivity or contraindications to GLP-1 receptor agonists as per product information;
- Current enrolment in another interventional trial;
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- Lactating, pregnant or at risk of pregnancy not willing to avoid pregnancy
- History of pancreatitis;
- History of medullary thyroid cancer;
- Current admission to a residential rehabilitation program or inpatient program or planned admission during the study period, which would interfere with participation in study visits or procedures;
- Currently experiencing psychosis or current active suicidality
- Any condition or circumstance that, in the opinion of the investigator, would compromise the participant's ability to comply with the study procedures, complete protocol requirements, or provide reliable data.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites
Alcohol & Drug Service, Metro Health North Brisbane
Brisbane, Queensland, 4000
Mark Daglish, +617 3837 5764, mark.daglish@health.qld.gov.au
Mark Daglish
Kirketon Road Centre
Darlinghurst, New South Wales, 2010
Phillip Read, +61 2 9360 2766, Phillip.Read1@health.nsw.gov.au
Phillip Read
Rankin Court Treatment Centre, St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
David Goodman-Meza, MD, PhD, dgoodman@kirby.unsw.edu.au
David Goodman-Meza
Next Step Drug and Alcohol Services
East Perth, Western Australia, 6004
Michael Christmass, +6189430 5966, michael.christmass@health.wa.gov.au
Michael Christmass
Drug and Alcohol Services, South Australia
Morphett Vale, South Australia, 5162
Katherine Senior, +618 8325 8111, Katherine.Senior@sa.gov.au
Katherine Senior
About this study
Methamphetamine use disorder is a major public health concern in Australia and globally. GLP-1 medications such as semaglutide (e.g. Ozempic) are approved for diabetes and medication, and may potentially affect craving for other substances apart from food. We do not know if this will help people who use methamphetamine ('ice') to reduce their use. This study will treat people who use methamphetamine with weekly injections of semaglutide. It will provide data on if this is a potentially safe and practical treatment for this group of people.
Read the detailed description
Methamphetamine use disorder is a major public health concern in Australia and globally, associated with high morbidity and limited treatment options. People with methamphetamine use disorder frequently face social marginalisation, psychiatric comorbidity, housing instability, and criminal justice involvement, contributing to poor treatment access and outcomes. At present, no pharmacotherapies have been approved for the treatment of methamphetamine use disorder. While several agents have demonstrated preliminary promise-including mirtazapine, which has shown consistent findings across trials-none have yet established sufficient efficacy to achieve regulatory approval. Ongoing registrational trials, such as those evaluating extended-release naltrexone combined with bupropion, and mirtazapine, may clarify the potential role of these agents in clinical practice.
Glucagon-like peptide-1 (GLP-1) receptor agonists, including semaglutide, are approved for diabetes and obesity and have central effects on reward pathways relevant to addiction. Preclinical studies show GLP-1 agonists reduce stimulant-related dopamine signalling and drug-seeking behaviour. Observational studies in humans suggest semaglutide may reduce risk of alcohol use disorder, hospitalisations related to substance use, and overdose, and a recent randomised controlled trial demonstrated reductions in cravings, and use of, alcohol and tobacco. However, no trials have yet evaluated semaglutide in methamphetamine use disorder. This pilot study will be the first to assess its feasibility, safety, and preliminary efficacy for methamphetamine use disorder.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- 12 weeks of weekly subcutaneous semaglutide injection
- Keywords
- Substance use disorder, Addiction, Drug use, Methamphetamine, Stimulants, GLP-1, Semaglutide, Ozempic, Wegovy
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks of weekly subcutaneous semaglutide injectionDrug
12 weeks of subcutaneous semaglutide administered once weekly, starting at 0.25 mg once weekly, titrated as tolerated up to 1.0 mg over the 12-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Adults with methamphetamine use disorder | Experimental | 12 weeks of subcutaneous semaglutide administered once weekly Receives: Drug: 12 weeks of weekly subcutaneous semaglutide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Outcome (exploratory)
Last 4-week methamphetamine use measured by the TLFB method at week 12 compared to screening
Measured: 12 weeks
Secondary outcomes (7)
Secondary exploratory outcome
Total number of days of self-reported methamphetamine use
Measured: 12 weeks
Secondary exploratory outcome
End-of-treatment abstinence from methamphetamine (self-reported and oral fluid drug screens);
Measured: 12 weeks
Secondary exploratory outcome
Use of, and end-of-treatment abstinence from, other substances (e.g., opioids, benzodiazepines, tobacco, alcohol).
Measured: 12 weeks
Secondary exploratory outcome
Change in methamphetamine craving score on visual analogue scale
Measured: 12 weeks
Secondary exploratory outcome
Weight loss
Measured: 12 weeks
Secondary exploratory outcome
Retention in opioid agonist treatment (OAT) programs at 12 weeks (for those enrolled in OAT)
Measured: 12 weeks
Secondary exploratory outcome
Change in health-related quality of life utility score on the EQ-5D-5L
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509112
- Sponsor's protocol ID
- VHCRP2502
- Acronym
- SHIFT
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study
- ClinicalTrials.gov ID
- NCT07509112
- Acronym / sponsor ID
- SHIFT / VHCRP2502
- Conditions
- Methamphetamine Use Disorder
- Keywords
- Substance use disorder, Addiction, Drug use, Methamphetamine, Stimulants, GLP-1, Semaglutide, Ozempic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methamphetamine use disorder is a major public health concern in Australia and globally. GLP-1 medications such as semaglutide (e.g. Ozempic) are approved for diabetes and medication, and may potentially affect craving for other substances apart from food. We do not know if this will help people who use methamphetamine ('ice') to reduce their use. This study will treat people who use methamphetamine with weekly injections of semaglutide. It will provide data on if this is a potentially safe and practical treatment for this group of people.
Detailed description
Methamphetamine use disorder is a major public health concern in Australia and globally, associated with high morbidity and limited treatment options. People with methamphetamine use disorder frequently face social marginalisation, psychiatric comorbidity, housing instability, and criminal justice involvement, contributing to poor treatment access and outcomes. At present, no pharmacotherapies have been approved for the treatment of methamphetamine use disorder. While several agents have demonstrated preliminary promise-including mirtazapine, which has shown consistent findings across trials-none have yet established sufficient efficacy to achieve regulatory approval. Ongoing registrational trials, such as those evaluating extended-release naltrexone combined with bupropion, and mirtazapine, may clarify the potential role of these agents in clinical practice.
Glucagon-like peptide-1 (GLP-1) receptor agonists, including semaglutide, are approved for diabetes and obesity and have central effects on reward pathways relevant to addiction. Preclinical studies show GLP-1 agonists reduce stimulant-related dopamine signalling and drug-seeking behaviour. Observational studies in humans suggest semaglutide may reduce risk of alcohol use disorder, hospitalisations related to substance use, and overdose, and a recent randomised controlled trial demonstrated reductions in cravings, and use of, alcohol and tobacco. However, no trials have yet evaluated semaglutide in methamphetamine use disorder. This pilot study will be the first to assess its feasibility, safety, and preliminary efficacy for methamphetamine use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with methamphetamine use disorder | Experimental | Drug: 12 weeks of weekly subcutaneous semaglutide injection12 weeks of subcutaneous semaglutide administered once weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has provided voluntary, written informed consent;
- Aged 18 years or older;
- Diagnosed with moderate to severe methamphetamine use disorder (DSM-5 criteria);
- Self-reported methamphetamine use on at least 14 of past 28 days and a positive oral fluid drug screen for amphetamine/methamphetamine;
- Willing and able to comply with study procedures and follow-up visits;
Key exclusion criteria (12 listed)
- Uncontrolled medical or psychiatric conditions that may interfere with participation;
- Body mass index less than 22 kg/m2;
- Confirmed diagnosis of diabetes mellitus (either known history of diabetes; concomitant treatment with insulin, metformin, sulfonylureas, thiazolidinediones, SGLT2 inhibitor, DPP4 inhibitor; or HbA1c >6.5 at screening);
- Currently taking a GLP-1 receptor agonist;
- Known hypersensitivity or contraindications to GLP-1 receptor agonists as per product information;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 weeks of weekly subcutaneous semaglutide injection12 weeks of subcutaneous semaglutide administered once weekly, starting at 0.25 mg once weekly, titrated as tolerated up to 1.0 mg over the 12-week study period. | Drug | Adults with methamphetamine use disorder |
Primary outcome
Efficacy Outcome (exploratory)
Time frame: 12 weeks
Last 4-week methamphetamine use measured by the TLFB method at week 12 compared to screening
7 secondary outcomes
Secondary exploratory outcome
Time frame: 12 weeks
Secondary exploratory outcome
Time frame: 12 weeks
Secondary exploratory outcome
Time frame: 12 weeks
Secondary exploratory outcome
Time frame: 12 weeks
Secondary exploratory outcome
Time frame: 12 weeks
Secondary exploratory outcome
Time frame: 12 weeks
Secondary exploratory outcome
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 12 weeks of weekly subcutaneous semaglutide injection in people with Methamphetamine Use Disorder, run by Kirby Institute at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Goodman-Meza, MD, PhD (+61 2 9385 0900, shiftstudy@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Outcome (exploratory) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.